Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

NCT ID: NCT00053417

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2003-12-31

Brief Summary

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Placebo control, twice a day (b.i.d.)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for 15 weeks

2

10 milligram (mg) fampridine b.i.d.

Group Type: EXPERIMENTAL

10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)

Intervention Type: DRUG

2 week up titration (10 mg)

12 weeks stable dose (10 mg)

1 week down titration (10 mg)

3

15 mg fampridine b.i.d.

Group Type: EXPERIMENTAL

15 mg fampridine-SR (4-aminopyridine, 4-AP)

Intervention Type: DRUG

10 mg twice daily for 1 week

15 mg twice daily for 14 weeks

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (15 mg)

1 week down titration (10 mg)

4

20 mg fampridine b.i.d.

Group Type: EXPERIMENTAL

20 mg fampridine-SR (4-aminopyridine, 4-AP)

Intervention Type: DRUG

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (20 mg)

1 week down titration (15 mg x 3 days, 10 mg x 4 days)

Interventions

Placebo

Placebo for 15 weeks

Intervention Type: DRUG

10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)

2 week up titration (10 mg)

12 weeks stable dose (10 mg)

1 week down titration (10 mg)

Intervention Type: DRUG

15 mg fampridine-SR (4-aminopyridine, 4-AP)

10 mg twice daily for 1 week

15 mg twice daily for 14 weeks

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (15 mg)

1 week down titration (10 mg)

Intervention Type: DRUG

20 mg fampridine-SR (4-aminopyridine, 4-AP)

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (20 mg)

1 week down titration (15 mg x 3 days, 10 mg x 4 days)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have a confirmed diagnosis of Multiple Sclerosis
• Are able to walk with or without an assisted device

Exclusion Criteria

• Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
• Participating in other investigational drug trials
• A medical history or clinical findings that preclude entry into the study
• A medication history that precludes entry into the study
• Previously treated with 4-aminopyridine (4-AP)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Acorda Therapeutics

Locations

Barrow Neurological Institute at St. Joseph Hospital and Medical Center

Phoenix, Arizona, United States

USC MS Comprehensive Care Center

Los Angeles, California, United States

Yale University MS Center

New Haven, Connecticut, United States

Shepherd Center

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Maryland at Baltimore

Baltimore, Maryland, United States

Fairview MS Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Gimbel MS Center

Teaneck, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Maimonides MS Care Center

Brooklyn, New York, United States

Mt. Sinai School of Medicine - MS Center

New York, New York, United States

University of Rochester Medical School

Rochester, New York, United States

SUNY Stony Brook

Stony Brook, New York, United States

Carolinas Medical Center MS Center

Charlotte, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oregon Health Sciences University; MS Center

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Texas-Houston

Houston, Texas, United States

Swedish Medical MS Center

Seattle, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Foothills Medical Centre

Calgary, Alberta, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Related Links

http://www.acorda.com

Related Info

Other Identifiers

MS-F202

Identifier Type: -

Identifier Source: org_study_id